Efficacy of Placebo Versus Chlorpheniramine for the Prevention of Allergic Transfusion Reactions.

NCT ID: NCT04688736

Last Updated: 2025-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

6642 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2027-06-30

Brief Summary

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This is a prospective, randomized, double-blind controlled trial to evaluate the efficacy of placebo versus chlorpheniramine for the prevention of allergic transfusion reactions.

Detailed Description

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Conditions

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Allergic Transfusion Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators
Neither patients nor medical staff, including physicians and nurses participating in this study, will know the group assignment after allocation.

Study Groups

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Placebo

Each recruited subject will oral 8mg placebo 20 minutes before blood transfusion.

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

The tablet resembles chlorpheniramine but has no therapeutic value.

Chlorpheniramine

Each recruited subject will oral 8mg chlorpheniramine 20 minutes before blood transfusion.

Group Type ACTIVE_COMPARATOR

Chlorpheniramine

Intervention Type DRUG

An antihistamine that reduces the natural chemical histamine in the body.

Interventions

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Placebo

The tablet resembles chlorpheniramine but has no therapeutic value.

Intervention Type DRUG

Chlorpheniramine

An antihistamine that reduces the natural chemical histamine in the body.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18\~65 years old.
* Subject is diagnosed with hematological disorder and requires blood product (i.e. suspended red blood cells, apheresis platelets, fresh frozen plasma) transfusions.
* Subject can fully understand and voluntarily sign informed consent forms.

Exclusion Criteria

* Subject with a history of allergic diseases.
* Subject experienced at least 1 moderate/severe or 2 mild allergic reactions in the past.
* Subject received glucocorticoid or allergy drugs within 24 hours before blood transfusion.
* Subject transfused with washed RBC.
* Received allo-HSCT transplantation before.
* Subject with heart failure.
* Subject suffered from sequelae of cardiovascular or cerebrovascular diseases.
* Pregnant or nursing women.
* Inability to understand or to follow study procedures.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Anhui Provincial Hospital

Hefei, Anhui, China

Site Status NOT_YET_RECRUITING

Zhoukou Central Hospital

Zhoukou, Henan, China

Site Status RECRUITING

The Second Affilated Hospital of Shandong First Medical University

Tai’an, Shandong, China

Site Status RECRUITING

Regenerative Medicine Center

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jun Shi, PhD

Role: CONTACT

(86)2223900913

Jingyu Zhao, MPH

Role: CONTACT

(86)13752253515

Facility Contacts

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Xiaoyu Zhu, PhD

Role: primary

Qian Liang, PhD

Role: primary

15703815972

Hong Zhang

Role: primary

18505386878

Jun Shi, PhD

Role: primary

(86)2223900913

Zhexiang Kuang, MN

Role: backup

Other Identifiers

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IIT2020032

Identifier Type: -

Identifier Source: org_study_id

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